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Clinical Quality Assurance Specialist
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Carthera, a French clinical-stage medtech company, is seeking a Quality Assurance Manager to join its clinical team in Lyon, France. The successful candidate will be responsible for ensuring the quality of clinical trials, adhering to good clinical practices and regulatory requirements.
Key Responsibilities
- Ensure compliance with quality standards, good clinical practices, and legal, ethical, and regulatory requirements
- Provide support to operational teams and ensure trials quality by setting up and maintaining appropriate documentation
- Contribute to the issuance and tracking of the Clinical Affairs' quality system and ensure it is appropriately documented and implemented
- Organize, plan, and monitor internal and external quality audits
- Carry out quality controls of clinical documentation/self-inspection
- Lead quality system changes and process improvement to support evolving regulations, new initiatives, and development of the company
- Raise awareness of Carthera's teams by organizing quality training programs per GxP requirements
- Perform other GCP duties and any cross-functional activities with R&D or QARA departments as assigned
Requirements
- Proven experience in Biotech/Pharmaceutical industry in clinics and QA with extensive knowledge of GCP Quality Management Systems
- Ideally, previous experience in medical device environment and/or medicines in international organizations
- Fluent in verbal and written English
What We Offer
- Competitive salary and benefits
- The opportunity to participate in the development of a disruptive technology in a fast-growing French/American company
- The chance to be part of a dynamic, friendly, and supportive team
About Carthera
Carthera is a clinical-stage medtech company focused on developing innovative ultrasound-based medical devices to treat a wide range of brain diseases. The company has developed the SonoCloud, an innovative medical device that emits ultrasound to temporarily increase the permeability of blood vessels in the brain.
